The present invention relates to a test kit for the collection and testing of urine samples for drugs of abuse having a cup-like container and a test card for indicating visually the presence of a particular drug of abuse, more particularly, to a closure cap for such a container having a self-sealing slot through which the test card is passed.
The increased availability and use of drugs of abuse by the general population has caused employers, governmental agencies, sports groups and other organizations to utilize drug screening both as a condition of employment and in order to maintain safety in the workplace. Typical drug screening tests are performed for the purpose of quickly identifying on a qualitative basis the presence of drugs in a body fluid which may be urine. A complete analysis of the sample may then be carried out in a laboratory only if the preliminary screening results are not negative. Increasingly, such drug screening procedures are taking place on site or at the workplace and are generally carried out by testing personnel who are usually not technically trained, such as laboratory technicians. It is thus important that the drug screening procedure be simple but yet reliable. Further, the test apparatus must be such so as to enable the testing personnel to avoid all contact with the fluid specimen which is being tested.
Various forms of devices have been proposed for the collection and taking of body fluids, such as urine, which have proved to be cumbersome in operation since they involve a number of separate steps. Initially, the sample was collected and several steps were then required to transfer the urine sample to an analysis device. This multiple step procedure required the manual handling of the specimen through various devices and the use of such transfer devices inevitably caused spills which could result in contamination to the tester and surroundings. In addition, non technical personnel who perform the screening tests on urine samples objected to coming into any kind of contact with the urine sample and even the handling of the sample itself.
One such testing device comprised a cup-like container which may be transparent for retaining a urine sample to be tested. The open top of the container has a removable closure cap and there is a diametrical slot in the cap. The slot is of such a size as to readily accommodate a test card which has a plurality of immunoassay test strips mounted thereon in parallel on one or both sides and each test strip is responsive to a particular drug of abuse. The test card is insertable through the slot so as to immerse one end in the urine sample to a predetermined depth whereby the visual results of each test strip may be seen through a transparent wall of the container or above the closure cap without removing the test card from the container so as to indicate the presence or absence of a particular drug of abuse in the urine sample. If the sample should test “positive” to indicate the presence of a drug in the urine, it is then necessary to send the sample to a certified laboratory for confirmatory testing. For this purpose, a second closure cap which is solid, i.e., without a slot, was provided which was threaded onto the open end of the cup-like container. The test card is removed from the container, the slotted cap is removed and replaced by the solid closure cap which is threaded on to close the container and the container is then ready for shipment to a laboratory.
However, prior to replacing the slotted cap with the solid cap it was found that occasionally the cup was accidentally tipped over while the card was still in the cup or after the card had been removed from the cup. In such an event, the liquid sample could and did spill from the slot in the cup onto surrounding surfaces and even into contact with the testing personnel. Thus, such open specimen containers posed a risk of contamination of the sample or specimens, contamination of the laboratory environment, loss of specimens through accidental spillage, and possible infection of personnel. It was therefore apparent that the handling and processing of urine and other similar liquid medical specimens should involve a minimum of opening and closing the specimen containers at the testing locations.